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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K961497
Device Name PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
Applicant
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070 -2584
Applicant Contact JOHN DICHIARA
Correspondent
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070 -2584
Correspondent Contact JOHN DICHIARA
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/18/1996
Decision Date 06/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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